DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The first paragraph of the specification includes an incomplete list (in comparison to the application data sheet) of the priority applications. Correction is required.
Paragraph [0085] appears to include a typo as fig. 12D can not show the details of itself. Correction is required.
Drawings
The drawings are objected to because fig. 10B is missing (there are two different figures labelled 10A, for the purposes of examination, Examiner is assuming one of the figures should be 10B). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 8 is/are objected to because of the following informalities:
Within claim 8, line 2: “of” is an extra word which does not make grammatical sense.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 2-3, 5-6 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Within claim 2, lines 2-4: Applicant claims, “a. deploying temporary valves above and below the native heart valve; b. establishing a flow path between the two additional temporary valves, thereby creating a space with no blood flow at the native valve”; there is insufficient written description for two temporary valves which create a space therebetween with no blood flow therethrough (as valves would not stop blood flow therethrough and would be incapable of creating a space therebetween with no blood flow). Examiner can only find support for a space with no blood flow created by two CUFFS (as opposed to VALVES) as seen in figs. 21A-21D and 23A-23F, specifications paragraphs [00121-00124, 00132-00138]). For the purposes of examination, Examiner is assuming the valves (of claim 2) are instead intended to be cuffs (consistent with the disclosure for creating a space with no blood flow therebetween). Claim(s) 3, 5-6, which depend from claim 2, inherit all the problems associated with claim 2.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Within claim 1, line 2: Applicant claims, “one or more temporary valves” (i.e. there could be two or more valve); additionally, within claim 1, lines 3-4: Applicant claims, “the temporary valve” (i.e. there can only be one valve); as such, it is unclear, and therefore indefinite, how many temporary valves are required of the claim – one OR one or more? Claim(s) 2-9, which depend from claim 1, inherit all the problems associated with claim 1.
Within claim 1, line 5: Applicant claims, “implanting a prosthetic valve”; it is unclear, and therefore indefinite, if this is the same as OR different from the implanted aortic heart valve (within claim 1, line 1).
Claim 2 recites the limitation "the two additional temporary valves" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 3, 5-6, which depend from claim 2, inherit all the problems associated with claim 2.
Claim 2 recites the limitation "the native valve" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, Examiner is assuming “the native valve” should be --the aortic heart valve-- (in order to link back to claim 1, line 1).
Claim 2 recites the limitation "the aortic valve region" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the procedure" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Within claim 3, line 2: Applicant clams, “cutting of diseased heart valve leaflets”; it is unclear, and therefore indefinite, if these are the same as OR different from the aortic leaflets (within claim 1, lines 7-8); additionally, it is unclear, and therefore indefinite, how the diseased leaflets can be cut (as required by the aforementioned claim) while also being grasped by the articulating arms (as required by claim 1, lines 7-8).
Within claim 4, line 2: Applicant clams, “cutting of diseased heart valve leaflets”; it is unclear, and therefore indefinite, if these are the same as OR different from the aortic leaflets (within claim 1, lines 7-8); additionally, it is unclear, and therefore indefinite, how the diseased leaflets can be cut (as required by the aforementioned claim) while also being grasped by the articulating arms (as required by claim 1, lines 7-8).
Within claim 5, line 2: Applicant clams, “cutting of diseased heart valve leaflets”; it is unclear, and therefore indefinite, if these are the same as OR different from the aortic leaflets (within claim 1, lines 7-8); additionally, it is unclear, and therefore indefinite, how the diseased leaflets can be cut (as required by the aforementioned claim) while also being grasped by the articulating arms (as required by claim 1, lines 7-8).
Claim 7 recites the limitation "the level" in 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the native aortic leaflets" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, Examiner is assuming “the native aortic leaflets” should be --the aortic leaflets-- (in order to link back to claim 1, lines 7-8).
Claim 7 recites the limitation "the coronary artery ostia" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Within claim 8, line 2: Applicant claims, “a frame with actuatable arms”; it is unclear, and therefore indefinite, if these are the same as OR in addition to the actuating arms (within claim 1, line 6).
Within claim 9, line 2: Applicant claims, “a prosthetic valve”; it is unclear, and therefore indefinite, if this is the same as OR in addition to the prosthetic valve (within claim 1, line 5).
Within claim 9, line 2: Applicant claims, “a frame of higher compliance”; it is unclear, and therefore indefinite, what the higher compliance is in relation to in order to qualify as “higher”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lutter (US 2005/0171472 A1) in view of LASCHINGER (US 2020/0253729 A1).
With respect to claim(s) 1-9:
Lutter discloses the invention substantially as claimed. Specifically, Lutter discloses a method of implanting an aortic heart valve, the method comprising:
deploying (positioning) one or more temporary valves (sluice positioned with the perfusion catheter) within an aorta of a patient (paragraphs [0032-0033]) (as required by claim 1);
establishing a blood path to supply coronary arteries (via the additional coronary perfusion catheters) of the patient while the temporary valve (sluice) is in place (paragraphs [0026, 0048]) (as required by claim 1);
Further comprising:
a. deploying temporary valves (dilation units 2, 3) above and below the native heart valve (aortic valve AK) (paragraphs [0041, 0053]) (as required by claim 2);
b. establishing a flow path (via the openings 6, 7) between the two additional temporary valves (dilation units 2, 3), thereby creating a space (working volume 5) with no blood flow at the native valve (aortic valve AK) (paragraphs [0041, 0053]) (as required by claim 2);
c. establishing a continuous optically clear fluid flush (pumped empty and rinsed) within the space (working volume 5) (paragraph [0054]) (as required by claim 2); and
d. using an optical camera (optical catheter) to visualize the aortic valve region to aid the procedure (paragraphs [0042, 0049]) (as required by claim 2).
And:
using a heart pump (pump) to aid flow between the two temporary valves (dilation units 2, 3) (paragraph [0046]) (as required by claim 3);
And:
a. cutting of diseased heart valve leaflets (partially extracted valve) to create space for the prosthetic valve (paragraph [0058]) (as required by claim(s) 4-6).
However, Lutter does not disclose the details associated with the prosthetic valve (new cardiac valve). Specifically, the prosthetic valve (new cardiac valve) comprising actuating arms nor the actuating of the actuating arms of the prosthetic valve (new cardiac valve) to securely grasp aortic leaflets of the patient (as required by claim 1); nor the exact location of the prosthetic valve (new cardiac valve) – specifically, implanting the prosthetic valve (new cardiac valve) at the level of the native aortic leaflets and below the coronary artery ostia (as required by claim 7); nor the prosthetic valve (new cardiac valve) comprising a frame with actuatable arms and a modular insertable and replaceable prosthetic leaflets that can be removed and replaced at a later date post procedure (as required by claim 8); nor the prosthetic valve (new cardiac valve) comprising a frame of high compliance, to reduce trauma and retain normal tissue compliance (as required by claim 9).
LASCHINGER teaches a method of implanting an aortic heart valve (universal valve device 100), as can be seen in figs. 9 and 11 (paragraph [0048]), the method comprising:
c. implanting a prosthetic valve (universal valve device 100) within the aorta of the patient, the prosthetic valve (universal valve device 100) comprising actuating arms (discs 116, 118) (paragraphs [0046, 0048]) (as required by claim 1);
d. actuating (deploying) the actuating arms (discs 116, 118) of the prosthetic valve (universal valve device 100) to securely grasp aortic leaflets (valve tissue 26 and/ or the annulus) of the patient (paragraphs [0046, 0048]) (as required by claim 1);
And:
a. implanting the prosthetic valve (universal valve device 100) at the level of the native aortic leaflets and below the coronary artery ostia (below coronary arteries) (paragraph [0046]) (as required by claim 7).
And:
a. implanting the prosthetic valve device (universal valve device 100) that comprises of a frame (frame 110) with actuatable arms (discs 116, 118) and a modular insertable and replaceable prosthetic leaflets (independent valve frame) that can be removed and replaced at a later date post procedure (individually interchanged/ replaced) (paragraph [0036]) (as required by claim 8);
And:
a. implanting the prosthetic valve (universal valve device 100) with a frame (frame 110) of high compliance, to reduce trauma and retain normal tissue compliance (the universal valve device 100, as taught by LASCHINGER, is considered high compliance as it has high flexibility and is easily manipulated) (paragraphs [0033, 0053]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the prosthetic valve (universal valve device 100) (including all the structures/ features thereof), as taught by LASCHINGER, for the prosthetic valve (new cardiac valve), as disclosed by Lutter, as both structures are used for the same purpose (to replace a diseased valve) within the same area of the body (the aortic valve) and are therefore functional equivalents and obvious substitutes for each other. In making the aforementioned combination, the actuating arms (discs 116, 118) of the prosthetic valve (universal valve device 100), as taught by LASCHINGER, will be used to securely grasp what remains of the partially extracted aortic leaflets (valve tissue 26) or the annulus, as disclosed by Lutter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/Primary Examiner, Art Unit 3774
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